Status:
COMPLETED
Progesterone in Expectantly Managed Early-onset Preeclampsia
Lead Sponsor:
Assiut University
Conditions:
Preeclampsia
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum
Detailed Description
Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyproge...
Eligibility Criteria
Inclusion
- Gestational age between 20+0 and 33+6 weeks.
- Singleton pregnancy.
- Willing to participate in the study and sign the informed consent.
Exclusion
- Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
- Platelet count \< 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
- Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
- Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
- Severe Oligohydramnios (AFI \< 5cm)
- Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
- Eclampsia;
- Nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations);
- Intrauterine fetal death.
- Patient is unable or unwilling to give consent.
- Patients currently using progesterone for other indications.
Key Trial Info
Start Date :
December 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04077853
Start Date
December 15 2019
End Date
January 15 2022
Last Update
May 9 2022
Active Locations (1)
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1
Ahmed Abbas
Assiut, Cairo Governorate, Egypt, 002